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Patient Satisfaction and OHRQoL In Removable Versus Fixed Implant Prostheses

2021年3月8日 更新者:Iman Abd-ElWahab Radi, PhD

Assessment Of Patient Satisfaction and Oral-health Related Quality of Life In Completely Edentulous Patients Receiving Removable Implant Overdentures Versus Fixed Implant Overdentures: A Randomized Clinical Trial

Objectives to evaluate the oral health-related quality of life and patient satisfaction in completely edentulous patients, when restored by maxillary and mandibular fixed (screw-retained) or removable telescopic retained implant supported prosthesis. 19 patients were randomized to receive either a fixed or a removable maxillary and mandibular full arch implant prosthesis. They were then asked to answer the OHIP-14 and a patient satisfaction questionnaire at 2 weeks, 3, 6 and 12 months post-prosthetic insertion.

調査の概要

詳細な説明

Interventions

General operative procedures:

Once the eligibility criteria were fulfilled in a patient, new complete maxillary and mandibular dentures were fabricated for this patient to allow for prosthetically driven implant placement. 4 implants were placed interforaminally so that they were parallel to each other. If the patient had an existing satisfactory denture, that was delivered at least six months ago, it was evaluated for retention, fit, support, stability, occlusion and esthetics. New and old dentures were later used for constructing the scan appliances.

The patients were randomly assigned into two groups with an allocation ratio 1:1. Simple randomization was done by preparing sequentially-numbered, opaque, sealed envelopes, that contained two-times folded cards with the treatment group written inside. Accordingly, the patients were assigned either to group T (control treatment/ telescopic retained implant supported removable overdentures) or group S (test treatment/ screw retained implant supported fixed prosthesis).

The intervention arm : Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.

the control treatment: Once adequate fit of the framework of the hybrid prosthesis was achieved, the wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth.

Lack of blinding of the operator, the participants and the assessor (patient) due to the obvious dissimilarity between the treatment arms, could have created performance and assessment bias. In an attempt to decrease the performance bias, randomization was delayed until the abutments were connected. When the prosthesis was delivered to the patient, they were requested to answer OHIP-14 and patient satisfaction questionnaires 2 weeks after prosthetic insertion, then 3, 6 and 12 months later.

The aim of this RCT was to evaluate patient satisfaction and oral-health related quality of life in completely edentulous patients receiving removable implant overdentures versus fixed implant hybrid restorations.

Data were statistically described in terms of mean +/- standard deviation (+/- SD), median and range. Comparison of ordinal variables between the study groups was done using Mann Whitney U test for independent samples. Within group comparison of the ordinal data was done using Friedmann test to detect significant differences between time in periods. This was followed by Wilcoxon signed rank test for paired comparisons. Two sided p values less than 0.05 was considered statistically significant. Additionally, a correlation between relevant domains of the OHIP-14 and the patient satisfaction questionnaires was done using Spearman rank correlation test. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows

研究の種類

介入

入学 (実際)

19

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Manial
      • Cairo、Manial、エジプト、12911
        • Faculty of Dentistry

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年~70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

説明

Inclusion Criteria:

  1. Completely edentulous male patients with an age range from 40- 70 years.
  2. Patients with a HbA1c equal to or less than 7
  3. All patients should have normal maxillo-mandibular relationship (Angle class I).
  4. Patients should have maxillary and mandibular ridges at least 7mm in width and 13 mm in height in the interforaminal areas and in the esthetic zones (premolar to premolar regions), respectively. This accommodated a pre-planned implant size of 3.7mm x 10 or 11mm.
  5. The maxillary and mandibular ridges should be covered by keratinized attached mucosa at least 5mm in width.
  6. An interarch space between the edentulous maxillary and mandibular ridges should not be less than 22 mm to accommodate the planned maxillary and mandibular implant-supported prostheses. This was confirmed by mounted diagnostic casts.
  7. Patients who were cooperative and who were psychologically and mentally stable as revealed from the initial interview with the patients were considered eligible.

Exclusion Criteria:

  • Females were excluded on purpose to prevent failures associated with osteoporosis and to avoid gender variability which definitely affects the results of patient satisfaction and OHIP.

    2. Patients requiring hard or, soft tissue grafting of the proposed implant sites.

    3. Heavy smokers (more than 10 cigarettes / day) or patients with para-functional habits like clenching or bruxism were excluded. This was important to decrease the risk of implant failure.

    4. Patients with temporo-mandibular joint disorders were considered ineligible because of the expected occlusal disturbances.

    5. Patients with systemic disease that might contra-indicate implants placement or affect osseointegration e.g. uncontrolled diabetes.

    6. Patients who took chemo-or radiotherapy or any drug that might counter-affect the healing process or the quality of bone.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Fixed implant supported prosthesis
the prosthesis is an all-on-four prosthesis composed of a hybrid prosthesis. a metal framework, acrylic resin denture base and acrylic resin teeth
Framework of the hybrid prosthesis is waxed using plastic copings attached to multiunit abutments. once the framework is finished , bite is recorded, teeth are set up and the waxed up prosthesis are tried in. IF accepted the wax is eliminated the wax up denture is converted inti heat cured acrylic resin
アクティブコンパレータ:Removable implant supported prosthesis
the prosthesis is an all-on-four prosthesis composed of a telescopic retained overdenture, both primary and secondary copings are custom made. the secondary copings are conncetd via a metal framework
The wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth. Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
patient satisfaction
時間枠:2 weeks after prosthetic insertion- 1 year
questionnaire. The patient satisfaction questionnaire is composed of 14 questions concerned with esthetics, speech, mastication, operative and prosthetic procedures, incidence of complications, pre-operative instructions, total time interval, cost, operator, hygienic procedures, overall experience as well as the willingness to repeat or refer others for the procedure.
2 weeks after prosthetic insertion- 1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
oral health related quality of life
時間枠:2 weeks after prosthetic insertion- 1 year
OHIP-14 scoring
2 weeks after prosthetic insertion- 1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Amira kheidr, masters、Cairo University
  • スタディディレクター:Amr El Khadem, phd、Cairo University
  • スタディチェア:Samira Ibrahim, phd、Cairo University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年11月1日

一次修了 (実際)

2018年9月30日

研究の完了 (実際)

2019年8月28日

試験登録日

最初に提出

2020年12月24日

QC基準を満たした最初の提出物

2021年1月1日

最初の投稿 (実際)

2021年1月5日

学習記録の更新

投稿された最後の更新 (実際)

2021年3月10日

QC基準を満たした最後の更新が送信されました

2021年3月8日

最終確認日

2021年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 151017

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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